Is NCT07575269 recruiting in Austin, TX?

Yes, NCT07575269 is currently recruiting participants at its Austin, TX location. This paroxysmal atrial fibrillation (paf) clinical trial is actively enrolling qualified participants.

How do I join the paroxysmal atrial fibrillation (paf) clinical trial in Austin?

To join this clinical trial in Austin, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Austin clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Paroxysmal Atrial Fibrillation (PAF) Clinical Trial in Austin, TX

About This Paroxysmal Atrial Fibrillation (PAF) Study in Austin

The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). The main question it aims to answer is: Is the FARAFLEX Mapping and PFA System a safe and effective treatment for patients? Participants will undergo an ablation procedure using the FARAFLEX Mapping and PFA System.

Sponsor: Boston Scientific Corporation

Who Can Participate

Inclusion Criteria

At least 18 years old (or older if required by local law)

Symptomatic, documented, drug-refractory paroxysmal or persistent atrial fibrillation (AF).

Willing and capable of providing written informed consent

Willing and able to comply with all follow-up assessments and study procedures at an approved investigational site

Exclusion Criteria

Any of the following atrial conditions:

Left atrial anteroposterior diameter of at least 5.5 cm, or if not available, non-indexed volume greater than 100 mL

Any prior atrial endocardial, epicardial, or surgical ablation for atrial arrhythmia (excluding right-sided Supraventricular Tachycardia (SVT) or Cavo-Tricuspid Isthmus (CTI)-dependent flutter)

Any prior atrial surgery

Current atrial myxoma

Pulmonary vein abnormality, stenosis, or prior stenting (common and middle pulmonary veins allowed)

Current left atrial thrombus

Any of the following cardiovascular conditions:

History of sustained ventricular tachycardia or ventricular fibrillation

Atrial fibrillation secondary to reversible or non-cardiac causes (e.g., electrolyte imbalance, thyroid disease, alcohol)

Presence of any of the following cardiac devices or implants:

Current or anticipated pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device

Current implantable loop recorder other than LUX-Dx

Prior interatrial baffle or septal closure device/patch (Patent Foramen Ovale (PFO)or Atrial Septal Defect (ASD))

Left atrial appendage closure or occlusion device

Clinically significant valvular disease, including:

Any cardiac valve prosthesis, ring, repair, or clip

Moderate to severe mitral stenosis

Moderate to severe aortic stenosis

Severe mitral regurgitation

Severe tricuspid regurgitation

Hypertrophic or amyloid cardiomyopathy

Presence of Inferior Vena Cava (IVC) filter, inability to obtain vascular access, or contraindication to femoral access

Awaiting cardiac transplantation or other cardiac surgery within 12 months (left atrial appendage closure/occlusion procedures allowed no less than (≥) 60 days after index procedure)

Severe right ventricular dysfunction per investigator assessment

Any of the following congenital conditions:

Congenital heart disease with clinically significant residual anatomic or conduction abnormalities, or channelopathies

Known congenital methemoglobinemia

Known G6PD deficiency

Any of the following medical history conditions:

Solid organ or hematologic transplant, or under evaluation for transplant

History or current evidence of hemi-diaphragmatic paralysis or paresis

Prinzmetal angina or severe non-revascularizable coronary disease

Known coagulopathy or bleeding disorder

Renal insufficiency, history of dialysis, or renal transplant

Known allergic reaction to nitroglycerin (excluding hypotension)

Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure

Active spinal cord stimulator

Any of the following baseline conditions:

NYHA Class III or IV heart failure

Left ventricular ejection fraction (LVEF) less than 40% within 12 months

CHA2DS2-VASc score greater than or equal to 5

Body mass index (BMI) greater than 45.0

Contraindication to or unwillingness to use systemic anticoagulation peri-procedurally

Pregnant or lactating at time of procedure

Severe lung disease, pulmonary hypertension, or oxygen-dependent lung disease

Active malignancy (excluding squamous cell carcinoma)

Clinically significant gastrointestinal disease (e.g., severe or erosive esophagitis, uncontrolled reflux, gastroparesis, esophageal candidiasis, active gastroduodenal ulceration)

Known Active systemic infection

Life expectancy of less than 1 year

Concurrent enrollment in another investigational study or registry that may interfere with this study (exceptions include mandatory governmental registries or purely observational registries with sponsor approval)

Any of the following events within 90 days prior to consent:

Myocardial infarction, unstable angina, or coronary intervention

Pericarditis or symptomatic pericardial effusion

Gastrointestinal bleeding

Cardiac surgery

Stroke, Transient Ischemic Attack (TIA), or intracranial bleeding

Any active non-neurologic thrombus and/or thromboembolic event

Carotid stenting or endarterectomy

Heart failure hospitalization

Uncontrolled diabetes mellitus or HbA1c greater than 8.0%

Other conditions:

Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted ICM from the LUX-Dx family of devices

Any medical condition that, in the investigator's opinion, would interfere with study participation, increase risk, or affect data interpretation

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Austin?

Yes, this clinical trial (NCT07575269) has an active research site in Austin, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Paroxysmal Atrial Fibrillation (PAF) Treatment Options in Austin, TX

If you're searching for paroxysmal atrial fibrillation (paf) treatment options in Austin, TX, this clinical trial (NCT07575269) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Austin research site is actively enrolling participants for this clinical trial. You'll receive care from experienced paroxysmal atrial fibrillation (paf) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all paroxysmal atrial fibrillation (paf) clinical trials near you to find additional studies recruiting in your area.

Paroxysmal Atrial Fibrillation (PAF) Clinical Trial in Austin, TX

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